Image based registration and intraoperative updating for guiding spine surgery

基于图像的配准和术中更新用于指导脊柱手术

• 批准号: 10001800
• 负责人: Sohail K Mirza
• 金额: $ 16.4万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10001800
• 关键词: Adopted; Adoption; Anatomy; Animal Experiments; Animals; Blood; Clinical; Clinical Trials; Complex; Complication; Data; Dose; Effectiveness; Europe; Excision; Exposure to; Failure; Goals; Gold; Hand; Hospitals; Human; Image; Image-Guided Surgery; Implant; Ionizing radiation; Liquid substance; Location; Manuals; Medicare; Methods; Microscope; Motion; Movement; Navigation System; North America; Operative Surgical Procedures; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Performance; Positioning Attribute; Postoperative Period; Procedures; Radiation; Randomized; Repeat Surgery; Respiration; Roentgen Rays; Series; Skin; Spinal; Spine surgery; Spondylolisthesis; Supination; Surface; Surgeon; System; Target Populations; Techniques; Technology; Time; Training; Translating; Update; Variant; Vertebral column; Work; X-Ray Computed Tomography; arm; base; bone; clinical implementation; cone-beam computed tomography; cost; experimental study; geometric structure; image guided; improved; improved outcome; innovation; lumbar vertebra bone structure; novel; portability; sample fixation; spine bone structure; standard of care

PROJECT SUMMARY Image-guidance has not been widely adopted in open lumbar fusion procedures because of cumbersome patient registration techniques. Accumulated mobility between vertebrae prohibits use of skin-affixed fiducials (requiring the surgeon to identify, expose, and localize anatomical landmarks within the surgical field), and registration at the start of surgery does not compensate for intervertebral motion between preoperative supine CT scans and intraoperative prone patient position. An automated registration procedure could accelerate adoption and improve outcomes, in addition to reducing costs, complexity, and x-ray dose associated with spine surgical guidance methods in current clinical use. Our target population is patients with symptomatic lumbar degenerative spondylolisthesis, where open decompression and fusion surgery, performed more than 300,000 times annually, improves patient-reported outcomes compared to non-surgical treatment. Image- guidance allows more accurate placement of pedicle screws, which could reduce revision rates and minimize patient harm, thereby allowing hospitals and surgeons to avoid reimbursement penalties from Medicare and other payers. We have developed an automated image-based intraoperative stereovision (iSV) to preoperative CT (pCT) registration that compensates for intervertebral motion, and have successfully applied the technique in two live animals, achieving excellent target registration errors (TREs less than 2.1 mm). We now propose to improve technical aspects of the approach in experimental studies and assess feasibility of this novel registration technology for clinical implementation. Specifically, we will (i) develop a portable iSV scanner as a radiation-free alternative to intraoperative CT (iCT) or O-arm, (ii) validate, evaluate and optimize the tehcnique in a systematic series of live animal surgeries, and (iii) translate the technology into a series of human cases of open lumbar fusion for degenerative spondylolisthesis. Comparisons of the new iSV approach to standard-of- care image-guidance with a commercial system (e.g., Medtronic StealthStation) and to high-fidelity navigation achieved with iCT will be performed to establish the relative performance improvements that can be obtained.

项目总结 由于操作繁琐，影像引导在开放式腰椎融合术中尚未被广泛采用。 病人登记技术。椎骨间累积活动度禁止使用贴皮基准物 (要求外科医生识别、暴露和定位外科领域内的解剖标志)；以及 手术开始时的定位不能补偿术前仰卧位之间的椎间运动 CT扫描和术中俯卧位。自动注册程序可能会加快 除降低成本、复杂性和与以下项目相关的X射线剂量外，还可采用和改善结果 目前临床上使用的脊柱手术指导方法。我们的目标人群是有症状的患者 腰椎退行性滑脱，其中开放减压和融合手术，执行超过 每年30万次，与非手术治疗相比，改善了患者报告的结果。图像- 引导可以更准确地放置椎弓根螺钉，从而降低翻修率和最小化 伤害患者，从而允许医院和外科医生避免联邦医疗保险和 其他付款人。我们已经开发了一种基于图像的自动化术中立体视觉(ISV)来在术前 补偿椎间运动的CT(PCT)配准，并已成功应用该技术 在两只活体动物中，实现了极好的目标配准误差(TRES小于2.1 mm)。我们现在建议 在实验研究中改进该方法的技术方面，并评估该新方法的可行性 注册技术在临床上的实施。具体地说，我们将(I)开发便携式ISV扫描仪作为 术中CT(ICT)或O-ARM的无辐射替代物，(Ii)验证、评估和优化技术 在一系列系统的活体动物手术中，以及(Iii)将这项技术转化为一系列人类病例 开放性腰椎融合术治疗退行性腰椎滑脱症。新的ISV方法与标准的比较 使用商业系统(例如美敦力隐蔽站)和高保真导航的CARE图像制导 将开展信息和通信技术方面的工作，以确定可以实现的相对业绩改进。